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Terminated

Langston Dual Lumen Catheter.

FDA Recall Z-0112-2021 · Posted 2020-10-20

Recalling FirmVascular Solutions, Inc.
Recall StatusTerminated
Product CodeDQO
Date Initiated2020-08-31
Date Terminated2024-06-18
Product Quantity1,745 units

Reason for Recall

The inner lumen of the Langston catheter may separate from the hub during pressure injection.

Firm Action

The firm notified consignees that received affected product on August 26, 2020 via UPS Mail (US), email or mail (OUS). The firms immediate correction is to recall the affected devices for destruction. The notice includes instructions on subrecall for any consignees that further distributed affected product.

Root Cause

Process control

Distribution Pattern

Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL ,GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ,NM ,NV ,NY ,OH ,OK,OR, PA ,PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY. International Distribution: Austria, Australia, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Oman, Poland, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051395LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETERVascular Solutions, Inc. · 2005-06-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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